This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in chronic kidney disease (CKD) patients either on dialysis or not receiving renal replacement therapy under treatment with Mircera or reference ESAs. Patients will be randomized to receive intravenous or subcutaneous Mircera at the following doses: for patients not already receiving ESA treatment Mircera will be administered at a starting dose of 0.6 micrograms/kg every 2 weeks; for patients receiving maintenance ESA treatment, intravenous or subcutaneous Mircera will be administered at an initial monthly dose of 120, 200 or 360 micrograms depending on the weekly dose of ESA received prior to first Mircera administration. Patients randomized to reference ESA treatment will receive intravenous or subcutaneous ESAs in accordance with their prescribed dosing information. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

A Randomized, Open Label Study to Assess All-cause Mortality and Cardiovascular Morbidity in Patients With Chronic Kidney Disease on Dialysis and Those Not on Renal Replacement Therapy Under Treatment With Mircera or Reference ESAs.

Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

male or female patients >18 years of age with symptomatic anemia associated with CKD;

patients with renal anemia (Hb <11.0g/dL) not treated with an ESA or on maintenance ESA therapy;

if receiving hemodialysis or peritoneal dialysis, with the same mode of dialysis for at least 3 months before screening, and continuous intravenous or subcutaneous maintenance therapy with ESAs at the same dosing interval for at least 2 months before screening;

Hb concentration between 10 and 12g/dL;

adequate iron status (ferritin >=100micrograms/L or TSAT >=20%.

Exclusion Criteria:

uncontrolled hypertension;

history of hemoglobinopathy;

anemia due to hemolysis;

pure red cell aplasia.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773513